Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures

NCT ID: NCT01238900

Last Updated: 2015-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2015-05-31

Brief Summary

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The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.

Detailed Description

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In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.

Conditions

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Benign Biliary Strictures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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benign biliary strictures

All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention Type PROCEDURE

Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

Interventions

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Endoscopic Retrograde Cholangiopancreatography (ERCP)

Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subject is 18 years or older
2. Subject has benign biliary stricture
3. Subject must be able to give informed consent

Exclusion Criteria

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
2. The subject is unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Draganov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Shands at UF endoscopy center

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Wagh MS, Chavalitdhamrong D, Moezardalan K, Chauhan SS, Gupte AR, Nosler MJ, Forsmark CE, Draganov PV. Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent. Diagn Ther Endosc. 2013;2013:183513. doi: 10.1155/2013/183513. Epub 2013 May 11.

Reference Type DERIVED
PMID: 23956613 (View on PubMed)

Other Identifiers

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Benign Biliary Strictures

Identifier Type: -

Identifier Source: org_study_id

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